The FDA's new proposal mandates that manufacturers of pulse oximeters gather more data regarding their efficacy across diverse racial groups, especially patients of color.
Research indicates that pulse oximeters can be inaccurate for patients with darker skin pigmentation, leading to potentially life-threatening delays in medical intervention.
The FDA's latest recommendations aim to enhance clinical study inclusivity by requiring enrollment of at least 150 patients with various skin tones.
This ongoing concern regarding the racial biases built into medical technology has prompted numerous discussions and studies undertaken by FDA regulators since 2022.
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